FDA Seeks Input on Tobacco Health Document Reporting Rules
Published Date: 6/27/2025
Notice
Summary
The FDA wants your thoughts on how they collect info about tobacco health documents. If you’re a tobacco company or health expert, this could affect how you submit important papers. They’re asking for comments over the next 60 days—no big costs, just a chance to help shape the rules!
No Economic Impacts Identified for this Document
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2026-16959, Frequently Asked Questions-Developing Potential Cellular and Gene Therapy Products; Final Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Frequently asked Questions--Developing Potential Cellular and Gene Therapy Products." The guidance document provides industry with answers to frequently asked questions (FAQs) and commonly faced issues that arise during the development of cellular and gene therapy (CGT) products. The FAQs represent common questions directed to the Agency and span multiple disciplines, including regulatory review; chemistry, manufacturing, and controls (CMC); pharmacology/toxicology; clinical; and clinical pharmacology. This guidance announced in this notice finalizes the draft guidance of the same title issued on November 19, 2024.
2026-16944, Gardenia Blue Interest Group; Filing of Color Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Gardenia Blue Interest Group (GBIG or petitioner), c/o Exponent, Inc., proposing that we amend our color additive regulations to expand the safe use of gardenia (genipin) blue in various foods at levels consistent with good manufacturing practice. The petition also proposes to lower the specification for arsenic in gardenia (genipin) blue.
2026-16943, International Association of Color Manufacturers; Filing of Color Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by the International Association of Color Manufacturers, proposing that we amend our color additive regulations to provide for the safe use of acetone as a solvent in the manufacture of carrot oil. The petition also proposes to add heavy metal limits and secondary names for carrot oil. FDA may also consider other changes to the regulation, as appropriate, during the course of our review.
Previous / Next Documents
Previous: 2025-11954, Darby Power, LLC, Gavin Power, LLC, Lawrenceburg Power, LLC, Waterford Power, LLC; Notice of Institution of Section 206 Proceeding and Refund Effective Date
The Federal Energy Regulatory Commission is checking if Darby Power, Gavin Power, Lawrenceburg Power, and Waterford Power are charging fair rates. If not, they might have to pay refunds starting from June 27, 2025. Anyone interested has 21 days to speak up and join the conversation.
Next: 2025-11956, Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
The FDA wants your thoughts on keeping records about animal proteins that can’t be used in cow feed to keep animals safe and healthy. This affects farmers, feed makers, and anyone involved in animal food, with no new costs but a chance to improve rules. You’ve got 60 days to share your ideas before the FDA decides what’s next!